Trial document




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  DRKS00010191

Trial Description

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Title

Patient Expectation and Treatment Outcomes of Acupuncture in Patients with Chronic Low Back Pain

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Trial Acronym

PATE (Pain Acupuncture Treatment Expectation)

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URL of the Trial

http://www.iki.usz.ch/Documents/Flyer_Akupunktur_2016_FINAL.pdf

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Brief Summary in Lay Language

Chronic low back pain (CLBP) is a highly prevalent medical condition and limit quality of life of such patients. Interventions from complementary medicine, such as acupuncture are effective to reduce pain and can be regarded as additional treatment option. In cohort studies patients’ treatment expectations also proved to be relevant for the treatment success of acupuncture. In other medical domains studies are available which aim at changing expectations before the treatment. However, studies aiming at changing expectations are limited so far. The project aims to test the effect of a verbal communication (briefing) to change patients’ expectations on the respective expectations and the treatment outcomes (pain and side effects). Patients suffering from CLBP will be included in the study and receive acupuncture treatment. Before their first treatment, patients receive different kinds of briefings concerning the beneficial effects and side effects of the acupuncture treatment. The effect of this different kind of information on expectations, pain and side effects of the acupuncture treatment will be evaluated.

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Brief Summary in Scientific Language

Chronic low back pain (CLBP) is a highly prevalent medical condition and CLBP patients often use acupuncture. Acupuncture can reduce chronic pain, which has been shown in clinical trials and meta-analyses. Patients with higher expectation for a favorable acupuncture outcome had more pain reduction regardless of the received acupuncture or sham acupuncture. The project aims to test the effect of a verbal communication (briefing) to change patients’ expectations on the respective expectations and the treatment outcomes (pain and side effects). Therefore, we use different briefing content. We compare regular expectation briefing with high expectation briefing (factor effectiveness) and regular side effects briefing with intense side effects briefing (factor side effects) in a 2x2 factorial design. The intervention (briefing sessions and written materials) is standardized and delivered before the treatment with additional boosters. Briefing content uses evidence-based information about the effectiveness and side effects of acupuncture for CLBP, however groups differ in the emphasized aspects of the information and the details provided. The treatment consists of 8 standardized minimal acupuncture sessions over 4 weeks. The primary intervention effects will be assessed 1) by measuring the expectation after the briefing and the pain intensity after the last acupuncture treatment and 2) scoring side effects and their intensity for all acupuncture treatments. Secondary outcomes are, among others, self-reported health.


The approved study protocol from the ethics committee was submitted before conducting the study with different types of briefings prior to the acupuncture treatment. It was pre-planned to blind the patients for the study aim and we presented this study as observational study in all public registries and other information. All patients were informed about the study aim after the intervention. Therefore we now adapted the description of the trial in the study registry according to the pre-specified study protocol.

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Organizational Data

  •   DRKS00010191
  •   2016/03/30
  •   [---]*
  •   yes
  •   Approved
  •   KEK-ZH-Nr. 2015-0511, Kantonale Ethikkommission Zürich
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M54.8 -  Other dorsalgia
  •   M54.9 -  Dorsalgia, unspecified
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Interventions/Observational Groups

  •   communication of physician with regular expectation / regular side effects briefing before acupuncture treatment
  •   communication of physician with regular expectation / intense side effects briefing before acupuncture treatment
  •   communication of physician with high expectation / regular side effects briefing before acupuncture treatment
  •   commmunication of physician with high expectation / intense side effects briefing before acupuncture treatment
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

1) Patient expectation after the briefing intervention (Expectation of Treatment Scale, ETS) and back pain (Numeric Rating Scale, NRS, 0 - 10), after the end of the acupuncture treatment (usually 4 weeks after treatment start); 2) side effects of acupuncture (side effect score after the end of the acupuncture treatment (usually 4 weeks after treatment start)

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Secondary Outcome

Back pain (NRS, 0 - 10), 2 weeks after treatment start, follow-up after 6 months;
Health (Patient-Reported Outcomes Measurement Information System PROMIS 29), 2 and 4 weeks after treatment start, follow-up after 6 months;
Working alliance (Working Alliance Inventory WAI-SR). 4 weeks after treatment start;
Rescue medication (diary), weekly;
Perceived Sensitivity to Medicines(PSM scale), 4 weeks after treatment start;
Bothersomeness pain (NRS, 0-10), 2 and 4 weeks after treatment start, follow-up after 6 months

Additional measures:
Optimism (Life Orientation Test, LOT), before the first treatment; Empathy with the physician (Consultation and Relational Empathy, CARE) before the first treatment

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/03/24
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Male and female patients aged 18 to 65 years with chronic non-specific low back pain (CLBP)
according to Deyo et al. (2014) with an average pain severity of at least 4 on a 0-10 numeric
rating scale and at least half of the days per months with pain in the last 6 months will be
eligible for this study.

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Exclusion Criteria

Patients will be excluded if they had have acupuncture treatment within the last 12 months; are
breast-feeding or are known pregnant, have a known blood coagulation disorder or take of
coagulation inhibiting drugs with the exception of aspirin. Furthermore they are excluded in case
of their CLBP being caused by a known malignant disease, trauma, the presence of a known
rheumatic or autoimmune disorder, a history or planned surgery of the spinal column of the low
back in the next 6 months, regular intake of analgesics (> once per week) because of additional
disease, intake of centrally-acting analgesics, regular intake of corticosteroids or injections with
corticosteroids within the last 8 weeks before randomization (specified in a studyspecific SOP), or a history of severe acute or chronic disorders that do not allow participation in the therapy.
Further exclusion criteria are known alcohol or substance abuse, insufficient German
language skills, current application for a pension claim.

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Addresses

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    • Institut für komplementäre und integrative MedizinUniversitätsSpital Zürich
    • Ms.  Prof. Dr.  Claudia  Witt 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    • Institut für komplementäre und integrative MedizinUniversitätsSpital Zürich
    • Mr.  PD Dr.  Jürgen  Barth 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    • UniversitätsSpital ZürichInstitut für komplementäre und integrative Medizin
    • Ms.  Alexandra  Kern 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    •   +41 (0)44 255 50 46
    •   [---]*
    •   pate at usz.ch
    •   [---]*
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Sources of Monetary or Material Support

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    • Schweizerischer Nationalfonds (SNF)
    • Wildhainweg 3
    • 3001  Bern
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/06
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.